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| Sponsors and Collaborators: |
Bayer ONYX Pharmaceuticals |
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00073307 |
Purpose
The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY 43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.
| Condition | Intervention | Phase |
|
Cancer Renal Cell Cancer (RCC) |
Drug: Nexavar (Sorafenib, BAY 43-9006) Drug: Placebo |
Phase III |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Sorafenib Sorafenib tosylate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Estimated Study Completion Date: | August 2009 |
| Arms | Assigned Interventions |
| Arm 2: Placebo Comparator |
Drug: Placebo
Placebo
|
| Arm 1: Experimental |
Drug: Nexavar (Sorafenib, BAY 43-9006)
Multi Kinase Inhibitor
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients who have three or more of the following:
Excluded therapies and medications, previous and concomitant:
Contacts and Locations![]() |
Show 19 Study Locations |
| Bayer |
| ONYX Pharmaceuticals |
| Study Chair: | Study Chair Bukowski, M.D. | Cleveland Clinic Cancer Center, Cleveland, Ohio, USA |
| Study Chair: | Study Chair J Escudier, MD | Institut Gustave Roussy (IGR), Villejuif, France |
More Information
| Responsible Party: | ( Bayer HealthCare AG, Therapeutic Area Head ) |
| Study ID Numbers: | 11213 |
| First Received: | November 19, 2003 |
| Last Updated: | December 31, 2007 |
| ClinicalTrials.gov Identifier: | NCT00073307 |
| Health Authority: | United States: Food and Drug Administration |
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